GORE Molding Occlusion Balloon Catheter MOB37Recalls & reported problems

Summary

The FDA's MAUDE database contains 152 adverse event reports that list this exact device (DI 00733132639489), received between Sep 26, 2018 and Sep 28, 2026 — classified as 6 deaths, 141 injuries, 5 malfunctions.

The most frequently reported specific device problem is “Patient Device Interaction Problem” (50 reports).

1 other recall cover devices cleared under the same FDA submission (K172567); they may or may not involve this specific model.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 152 reports, in the reporter's own words as published by the FDA.

• InjurySep 28, 2026Adverse Event Without Identified Device or Use Problem

  The following was reported to Gore:On (b)(6) 2026, the patient underwent endovascular treatment of a thoracoabdominal aortic aneurysm. A GORE® EXCLUDER® Thoracoabdominal Branch Endoprosthesis, a GORE® TAG® Conformable Thoracic Stent Graft with ACTIVE CONTROL System and four GORE® VIABAHN® VBX Balloon Expandable Endoprosthesis devices were implanted using two GORE® DrySeal Flex Introducer Sheath (22Fr and 14Fr), a GORE® Tri Lumen Catheter and a GORE® Molding & Occlusion Balloon Catheter.The 22Fr GORE® DrySeal Flex Introducer Sheath was inserted from the left femoral artery and the 14Fr GORE® DrySeal Flex Introducer Sheath was inserted from the left axillary artery.After implantation of all devices, angiography revealed a rupture and dissection extending from the left external iliac artery to the left common femoral artery. A GORE® VIABAHN® VBX Balloon Expandable Endoprosthesis and a GORE® VIABAHN® Endoprosthesis with Heparin Bioactive Surface were implanted in the left external iliac artery to treat the rupture. Subsequently, the 22 Fr GORE® DrySeal Flex Introducer Sheath inadvertently backed out. Two additional GORE® VIABAHN® VBX Balloon Expandable Endoprosthesis devices were impla

  Patient problems: Embolism/Embolus; Ischemia

  MAUDE report 50911714 ↗
• InjurySep 15, 2026Adverse Event Without Identified Device or Use Problem

  The following was reported to Gore from the iMedidata database: On (b)(6), 2026, the patient underwent endovascular treatment for an aortoiliac aneurysm. The patient was treated with GORE®¿EXCLUDER®¿Conformable AAA Endoprosthesis, GORE® EXCLUDER® AAA Endoprosthesis devices and GORE®¿EXCLUDER®¿Iliac Branch Endoprosthesis devices. The GORE® devices were successfully navigated to the intended location and successfully deployed. On (b)(6), 2026, the patient developed an infected inguinal pseudoaneurysm. A percutaneous transluminal angioplasty was performed to treat it.On (b)(6), 2026, the infected inguinal pseudoaneurysm was recovered / resolved with sequelae.

  Patient problems: Pseudoaneurysm; Unspecified Infection

  MAUDE report 50768468 ↗
• InjuryJul 30, 2026Adverse Event Without Identified Device or Use Problem

  It was reported to Gore that, on (b)(6)2026, the patient underwent Zone 2 endovascular treatment for a thoracic aortic aneurysm using the GORE® TAG® Thoracic Branch Endoprostheses and GORE® TAG® Conformable Thoracic Stent Graft with ACTIVE CONTROL System. The GORE® DrySeal Flex Introducer Sheath and GORE® Molding & Occlusion Balloon Catheter were also used as accessories.A 22Fr sheath was inserted via the right common femoral artery; however, resistance was encountered at the right external iliac artery, preventing further advancement. Angioplasty of the common iliac artery and external iliac artery was performed using a PTA balloon, and sheath insertion was attempted again. Despite vessel dilation, the sheath could not be advanced beyond the right common iliac artery. Therefore, each device was advanced individually without the sheath. Subsequently, the CTAG and the Aortic Component were deployed, followed by deployment of the Side Branch Component in the left subclavian artery. Balloon dilation was then performed using the MOB balloon catheter.Access angiography demonstrated suspected pseudoaneurysm at the proximal portion of the right common iliac artery. However, no additional

  Patient problems: Pseudoaneurysm

  MAUDE report 50085840 ↗
• InjuryApr 6, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED TO GORE THAT ON (B)(6) 2026, THE PATIENT UNDERWENT ENDOVASCULAR TREATMENT FOR AN ABDOMINAL AORTIC ANEURYSM USING THE GORE EXCLUDER AAA ENDOPROSTHESES, ALONG WITH THE GORE MOLDING & OCCLUSION BALLOON CATHETER AND THE GORE DRYSEAL FLEX INTRODUCER SHEATHS AS ACCESSORIES. IT WAS FURTHER REPORTED THAT TWO SHEATHS¿A 12 FR SHEATH AND AN ANEURYSM COIL SHEATH¿WERE INSERTED SIMULTANEOUSLY VIA THE LEFT COMMON FEMORAL ARTERY. AFTER DEPLOYMENT OF THE STENT GRAFTS, BALLOON DILATION WITH A MOB BALLOON WAS PERFORMED ON THE LEFT LIMB (PLC141000J). SUBSEQUENT ANGIOGRAPHY REVEALED A SUSPECTED DISSECTION OF THE LEFT COMMON ILIAC ARTERY, AS WELL AS DECREASED BLOOD FLOW IN THE LEFT INTERNAL ILIAC ARTERY. AN ADDITIONAL STENT GRAFT WAS PLACED TO EXTEND THE LEFT LIMB AS PART OF THE TREATMENT. ALTHOUGH BLOOD FLOW IN THE LEFT INTERNAL ILIAC ARTERY REMAINED REDUCED, THE PROCEDURE WAS COMPLETED WITH THE PATIENT PLACED UNDER OBSERVATION.

  Patient problems: Vascular Dissection

  MAUDE report 24787825 ↗
• InjuryMar 3, 2026Patient Device Interaction Problem

  THE FOLLOWING INFORMATION WAS REPORTED TO GORE: ON (B)(6) 2026, THE PATIENT UNDERWENT ENDOVASCULAR TREATMENT FOR AN ABDOMINAL AORTIC ANEURYSM USING GORE® EXCLUDER® CONFORMABLE AAA ENDOPROSTHESIS AND GORE® EXCLUDER®AAA ENDOPROSTHESIS DEVICES. FOLLOWING DEPLOYMENT OF THESE DEVICES, A BALLOON TOUCH-UP WAS PERFORMED USING A GORE® MOB BALLOON CATHETER. SUBSEQUENT ANGIOGRAPHY CONFIRMED A DISTAL TYPE I ENDOLEAK ORIGINATING FROM THE RIGHT DISTAL SIDE. AFTER ADDITIONAL BALLOON TOUCH-UP WAS PERFORMED AT THE SITE USING THE MOB BALLOON, A VESSEL INJURY RESEMBLING A DISSECTION OCCURRED IN THE RIGHT COMMON ILIAC ARTERY. AS A TREATMENT, COIL EMBOLIZATION OF THE RIGHT INTERNAL ILIAC ARTERY WAS PERFORMED, FOLLOWED BY PLACEMENT OF AN ADDITIONAL STENT GRAFT EXTENDING TO THE RIGHT EXTERNAL ILIAC ARTERY TO RESOLVE THE ENDOLEAK. THE PATIENT TOLERATED THE PROCEDURE. THE PHYSICIAN REPORTED THAT EXCESSIVE BALLOON PRESSURE HAD BEEN APPLIED DURING THE BALLOON TOUCH-UP. THE ANATOMICAL CONFIGURATION MADE IT CHALLENGING TO ACHIEVE A SECURE DISTAL LANDING ZONE IN THE RIGHT COMMON ILIAC ARTERY. THEREFORE, AGGRESSIVE BALLOONING IN RESPONSE TO THE DISTAL TYPE I ENDOLEAK SHOULD HAVE BEEN AVOIDED.

  Patient problems: Perforation of Vessels

  MAUDE report 24492828 ↗
• InjuryFeb 26, 2026Adverse Event Without Identified Device or Use Problem

  THE FOLLOWING INFORMATION WAS REPORTED TO GORE: ON (B)(6) 2026, THIS PATIENT UNDERWENT AN ENDOVASCULAR TREATMENT FOR ABDOMINAL AORTIC ANEURYSM USING GORE® EXCLUDER® CONFORMABLE AAA ENDOPROSTHESIS. GORE® MOLDING & OCCLUSION BALLOON CATHETER WAS ALSO USED. DURING THE PROCEDURE, AN ANGIOGRAPHY SHOWED A SUSPECTED TYPE IA ENDOLEAK OR LOCALIZED DISSECTION AROUND THE AORTIC NECK FOLLOWING SUCCESSFUL DEPLOYMENT OF THE TRUNK-IPSILATERAL LEG AND BALLOONING. AN ADDITIONAL AORTIC EXTENDER WAS DEPLOYED, BUT THAT FINDING REMAINED THOUGH IT BECAME MINOR. CONSIDERING A POSSIBILITY OF DISSECTION, NO ADDITIONAL BALLOONING WAS PERFORMED. THE PATIENT TOLERATED THE PROCEDURE. THE REPORTING PHYSICIAN COMMENTED AS FOLLOWS: THE PATIENT¿S AORTIC NECK CONDITION WAS POOR AND IT WAS CONSIDERED THAT LOCALIZED AORTIC DISSECTION OCCURRED DURING THE INITIAL BALLOONING. GIVEN THE DEVICE POSITIONING AND THE FACT THAT THE CONTRAST EFFECT DID NOT REACH THE ANEURYSM SAC, IT WAS PROBABLY NOT A TYPE IA ENDOLEAK.

  Patient problems: Vascular Dissection

  MAUDE report 24453263 ↗
• InjuryFeb 21, 2026Improper or Incorrect Procedure or Method

  THE FOLLOWING WAS REPORTED TO GORE: ON (B)(6) 2026, A PATIENT WAS BEING TREATED FOR AN ABDOMINAL AORTIC ANEURYSM USING A GORE® EXCLUDER® AAA ENDOPROSTHESIS SYSTEM. A GORE® MOLDING & OCCLUSION BALLOON WAS USED FOR BALLOONING. AFTER DEPLOYMENT OF A PLC141000 DEVICE, THE PHYSICIAN BALLOONED THE ILIAC ARTERY. WHILE THE PHYSICIAN WAS BALLOONING, SOMETHING IN THE ILIAC APPEARED TO POP ON THE FLUORO, AND ABOUT 5 SECONDS LATER THE PATIENT'S BLOOD PRESSURE DROPPED. THE PHYSICIAN TOOK AN ANGIO AND SAW THAT THE ILIAC HAD RUPTURED WITH EXTRAVASATION. THE PHYSICIAN RELINED THE ILIAC ARTERY WITH TWO PLC121400 DEVICES. THE RUPTURE WAS RESOLVED, AND THE PATIENT TOLERATED THE PROCEDURE, AND WAS DISCHARGED FROM THE HOSPITAL (B)(6) 2026. REPORTEDLY, THE ILIAC ARTERY WAS STENOTIC AND CALCIFIED PRIOR TO THE PROCEDURE.

  Patient problems: Perforation of Vessels

  MAUDE report 24409092 ↗
• InjuryFeb 3, 2026Patient Device Interaction Problem

  THE FOLLOWING INFORMATION WAS REPORTED TO GORE: ON (B)(6) 2026, THIS PATIENT UNDERWENT AN ENDOVASCULAR TREATMENT FOR ABDOMINAL AORTIC ANEURYSM USING GORE® EXCLUDER® AAA ENDOPROSTHESIS AND GORE® MOLDING & OCCLUSION BALLOON CATHETER. THE FINAL ANGIOGRAPHY SHOWED AN AORTIC DISSECTION PROXIMAL TO THE TRUNK-IPSILATERAL LEG. AN ADDITIONAL AORTIC EXTENDER WAS PLACED TO COVER THE DISSECTION. THE PATIENT TOLERATED THE PROCEDURE. THE REPORTING PHYSICIAN COMMENTED AS FOLLOWS: THE DISSECTION OCCURRED PROBABLY DURING A SERIES OF DEVICE MANIPULATION, ESPECIALLY BALLOONING TO THE STENT GRAFTS. REPORTEDLY, THE AORTIC DISSECTION DID NOT CONTACT THE PROXIMAL END OF THE DEVICE. ADDITIONALLY, DURING BALLOON INFLATION, THE BALLOON SEEMED POSITIONED SLIGHTLY BEYOND THE PROXIMAL END OF THE STENT GRAFT.

  Patient problems: Vascular Dissection

  MAUDE report 24243315 ↗
• InjuryJan 6, 2026Patient Device Interaction Problem

  IT WAS REPORTED TO GORE THAT ON (B)(6) 2025, THE PATIENT UNDERWENT EMERGENCY ENDOVASCULAR TREATMENT FOR A RUPTURED ABDOMINAL AORTIC ANEURYSM USING GORE EXCLUDER AAA ENDOPROSTHESES. AFTER DEPLOYMENT OF THE TRUNK IPSILATERAL LEG, IT MIGRATED DISTALLY DURING BALLOON INFLATION. AN AORTIC EXTENDER (PLA230300J/(B)(6)) WAS SUBSEQUENTLY PLACED PROXIMALLY, AND THE MOB BALLOON WAS INFLATED IN A POSITION PROTRUDING FROM THE PROXIMAL END, WHICH RESULTED IN A SUDDEN DROP IN BLOOD PRESSURE. ANGIOGRAPHY CONFIRMED RUPTURE OF THE AORTA DISTAL TO THE LEFT RENAL ARTERY AND RETROGRADE DISSECTION. AN ADDITIONAL AORTIC EXTENDER (PLA230300J/(B)(6)) WAS DEPLOYED; HOWEVER, IT DID NOT COMPLETELY COVER THE RUPTURE SITE, AND EXTRAVASATION PERSISTED. ANOTHER AORTIC EXTENDER (PLA260300J/(B)(6)) WAS THEN PLACED, EXTENDING TO JUST BELOW THE SUPERIOR MESENTERIC ARTERY. THE PATIENT TOLERATED THE PROCEDURE.

  Patient problems: Perforation of Vessels; Vascular Dissection

  MAUDE report 23973229 ↗
• InjuryDec 22, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE FOLLOWING WAS REPORTED TO GORE: ON (B)(6) 2025, THE PATIENT UNDERWENT ENDOVASCULAR TREATMENT FOR AN IMPENDING RUPTURE OF AN ABDOMINAL AORTIC ANEURYSM USING GORE® EXCLUDER® CONFORMABLE AAA ENDOPROSTHESIS, GORE® EXCLUDER® AAA ENDOPROSTHESIS GORE® DRYSEAL FLEX INTRODUCER SHEATH AND GORE® MOLDING & OCCLUSION BALLOON CATHETER. AFTER THE PROXIMAL END OF THE TRUNK IPSILATERAL LEG ENDOPROSTHESIS (GORE® EXCLUDER® CONFORMABLE AAA ENDOPROSTHESIS) WAS DEPLOYED, CANNULATION OF THE CONTRALATERAL GATE WAS ATTEMPTED VIA THE RIGHT ACCESS. HOWEVER, THE WIRE AND CATHETER COULD NOT BE ADVANCED THROUGH THE ORIGIN OF THE RIGHT COMMON ILIAC ARTERY. IT WAS REPORTED THAT THE ORIGIN OF THE RIGHT COMMON ILIAC ARTERY WAS VERY NARROW AND TORTUOUS. THE TRUNK IPSILATERAL LEG ENDOPROSTHESIS WAS FULLY DEPLOYED AND A TOUCH-UP WAS PERFORMED. THEN, CANNULATION FROM THE LEFT SIDE TO THE RIGHT COMMON ILIAC ARTERY WAS ATTEMPTED, BUT IT COULD NOT BE ADVANCED THROUGH THE RIGHT COMMON ILIAC ARTERY. AFTER SEVERAL ATTEMPTS, ANGIOGRAPHY WAS PERFORMED, REVEALING THAT THE RIGHT COMMON ILIAC ARTERY WAS COMPLETELY OCCLUDED. THE PROCEDURE WAS CONVERTED TO AN AORTOUNILIAC (AUI) PROCEDURE WITH A FEMORAL-FEMORAL ARTERY BYPASS. A

  Patient problems: Embolism/Embolus

  MAUDE report 23861660 ↗
• InjuryDec 19, 2025Patient Device Interaction Problem; Patient Device Interaction Problem

  THE FOLLOWING WAS REPORTED TO GORE: ON (B)(6) 2025, THE PATIENT UNDERWENT ENDOVASCULAR TREATMENT OF AN ABDOMINAL AORTIC ANEURYSM USING GORE® EXCLUDER® CONFORMABLE AAA ENDOPROSTHESIS DEVICES AND GORE® EXCLUDER® AAA ENDOPROSTHESIS DEVICES. AFTER ALL DEVICES WERE IMPLANTED, FINAL ANGIOGRAPHY REVEALED A RUPTURE IN THE RIGHT COMMON ILIAC ARTERY. IT WAS REPORTED THAT THE RUPTURE MIGHT HAVE OCCURRED WHEN A TOUCH-UP BALLOONING USING A GORE® MOLDING & OCCLUSION BALLOON CATHETER WAS PERFORMED ON A CONTRALATERAL LEG ENDOPROSTHESIS IMPLANTED IN THE RIGHT COMMON ILIAC ARTERY. AN ADDITIONAL ILIAC EXTENDER ENDOPROSTHESIS WAS IMPLANTED TO COVER THE RUPTURE SITE, EXTENDING THE FIRST CONTRALATERAL LEG TO THE RIGHT EXTERNAL ILIAC ARTERY. THE PATIENT TOLERATED THE PROCEDURE.

  Patient problems: Perforation of Vessels

  MAUDE report 23847498 ↗
• InjuryDec 2, 2025Patient Device Interaction Problem; Patient Device Interaction Problem

  THE FOLLOWING INFORMATION WAS REPORTED TO GORE: ON (B)(6) 2025, THE PATIENT UNDERWENT ENDOVASCULAR TREATMENT FOR AN ABDOMINAL AORTIC ANEURYSM USING GORE® EXCLUDER® CONFORMABLE AAA ENDOPROSTHESIS AND GORE® EXCLUDER®AAA ENDOPROSTHESIS DEVICES. A GORE® MOLDING & OCCLUSION BALLOON CATHETER (MOB) WAS USED AS AN ACCESSORY. DUE TO SEVERE ANGULATION OF THE PROXIMAL NECK, THE SHEATH WAS INSERTED USING A PULL-THROUGH WIRE TECHNIQUE. AFTER DEPLOYING THE TRUNK-IPSILATERAL LEG ENDOPROSTHESIS JUST BELOW THE LEFT RENAL ARTERY, LEGS WERE PLACED BOTH ON THE RIGHT AND LEFT SIDES. SUBSEQUENTLY, BALLOON TOUCH-UP BY MOB WAS PERFORMED FROM THE PROXIMAL END TO THE DISTAL SEGMENT. ANGIOGRAPHY REVEALED AN ANTEGRADE DISSECTION NEAR THE PROXIMAL NECK OF THE TRUNK DEVICE. AN AORTIC EXTENDER ENDOPROSTHESIS WAS ADDED PROXIMALLY TO EXTEND THE PROXIMAL NECK BY APPROXIMATELY 1 CM. BALLOON TOUCH-UP WAS NOT PERFORMED, AND FOLLOW-UP ANGIOGRAPHY CONFIRMED RESOLUTION OF THE ANTEGRADE DISSECTION AT THE PROXIMAL NECK. HOWEVER, SUBSEQUENT TRANSESOPHAGEAL ECHOCARDIOGRAPHY REVEALED A RETROGRADE DISSECTION EXTENDING TO THE THORACIC ARCH. IT WAS CONFIRMED THAT THE DISSECTION DID NOT REACH THE ASCENDING AORTA, AND THE PATIENT

  Patient problems: Vascular Dissection

  MAUDE report 23700671 ↗
• InjuryNov 27, 2025Patient Device Interaction Problem; Patient Device Interaction Problem

  THE FOLLOWING LITERATURE WAS REVIEWED. "RETROGRADE TYPE A DISSECTION AND RUPTURE OF THE AORTIC ROOT DURING ENDOVASCULAR AORTIC REPAIR" ISHIDA S, IHARA T, MORI A, YAGAMI K. J SURG CASE REP. 2025 OCT 17;2025(10):RJAF823. DOI: 10.1093/JSCR/RJAF823. AN 80-YEAR-OLD WOMAN PRESENTED WITH A PROGRESSIVELY ENLARGING INTRARENAL AAA, MEASURING UP TO 50 MM. THE PATIENT¿S PERFORMANCE STATUS WAS RELATIVELY LOW; THEREFORE, EVAR WAS SELECTED TO TREAT THE AAA INSTEAD OF OPEN SURGERY. EVAR WAS PERFORMED UNDER LOCAL ANESTHESIA, AND THE PROCEDURE WAS CONDUCTED AS USUAL. BALLOONING WAS PERFORMED AFTER IMPLANTING GORE® EXCLUDER® CONFORMABLE AAA ENDOPROSTHESIS AND GORE® EXCLUDER® AAA CONTRALATERAL LEG ENDOPROSTHESIS. SUBSEQUENTLY, AORTOGRAPHY WAS PERFORMED, WHICH SHOWED A PROXIMAL TYPE I ENDOLEAK. THEREFORE, BALLOONING WAS ADDED AT THE TOP OF THE TRUNK-IPSILATERAL LEG ENDOPROSTHESIS (MAIN BODY STENT GRAFT); HOWEVER, THE ENDOLEAK PERSISTED. THUS, AN ADDITIONAL AORTIC EXTENDER ENDOPROSTHESIS WAS IMPLANTED AT THE UPPER END OF THE MAIN BODY STENT GRAFT. AORTOGRAPHY WAS PERFORMED AFTER BALLOONING; HOWEVER, THE FLOW WAS STAGNATING IN THE STENT GRAFT. AT THE SAME TIME, THE PULSE RATE OF THE PATIENT DECREASED SUD

  Patient problems: Cardiac Tamponade; Perforation of Vessels; Vascular Dissection

  MAUDE report 23663332 ↗
• InjuryNov 26, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE FOLLOWING WAS REPORTED TO GORE: ON (B)(6) 2025, THE PATIENT UNDERWENT ENDOVASCULAR TREATMENT FOR STENOSIS AT THE ANASTOMOSIS OF A Y GRAFT REPLACEMENT FOR THE ABDOMINAL AORTA USING A NON-GORE GRAFT AT THE LEFT COMMON ILIAC ARTERY (SUSPECTED PSEUDOANEURYSM). GORE® EXCLUDER® CONFORMABLE AAA ENDOPROSTHESIS AND GORE® EXCLUDER® AAA ENDOPROSTHESIS DEVICES WERE USED FOR THIS EVAR PROCEDURE. A 16FR GORE® DRYSEAL FLEX INTRODUCER SHEATH WAS INSERTED FROM THE LEFT SIDE AND A 12FR GORE® DRYSEAL FLEX INTRODUCER SHEATH FROM THE RIGHT SIDE, THEN ALL DEVICES WERE IMPLANTED. IT WAS REPORTED THAT THE 12FR GORE® DRYSEAL FLEX INTRODUCER SHEATH WAS INSERTED FROM THE RIGHT SIDE AFTER CLAMPING THE RIGHT FEMORAL ARTERY TO PREVENT THROMBOTIC OCCLUSION OF THE PERIPHERAL ARTERY. AFTER STENT GRAFTS WERE IMPLANTED, DOPPLER EXAMINATION REVEALED POOR BLOOD FLOW IN THE RIGHT PERIPHERAL ARTERY. ANGIOGRAPHY SHOWED STENOSIS/OCCLUSION NEAR THE POPLITEAL ARTERY. THROMBECTOMY USING A FOGARTY CATHETER WAS PERFORMED. IT WAS REPORTED THAT THROMBI WERE OBSERVED FROM THE INFRARENAL AORTA TO THE PERIPHERAL ARTERIES. THE PHYSICIAN STATED THAT THE RIGHT FEMORAL ARTERY WAS CLAMPED TO PREVENT THROMBOTIC OCCLUSION OF THE PERIP

  Patient problems: Embolism/Embolus

  MAUDE report 23663172 ↗
• InjuryNov 21, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE FOLLOWING WAS REPORTED: ON (B)(6) 2025, THE PATIENT WAS IMPLANTED WITH GORE® EXCLUDER® AAA ENDOPROSTHESIS TO TREAT AN ABDOMINAL AORTIC ANEURYSM. IT WAS REPORTED THAT THE PHYSICIAN WHILE BALLOONING (WITHIN THE DEVICE) THE RIGHT ILIAC ARTERY DEVICE, THE ARTERY DISSECTED. THE PHYSICIAN EXTENDED THE DEVICES IN THE EXTERNAL ILIAC ARTERY WITH TWO ADDITIONAL DEVICES AND USED A AMPLATZER PLUG TO BLOCK BLOOD FLOW INTO THE HYPOGASTRIC ARTERY. THE PATIENT TOLERATED THE PROCEDURE.

  Patient problems: Vascular Dissection

  MAUDE report 23619075 ↗
• InjuryNov 19, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE FOLLOWING INFORMATION WAS REPORTED TO GORE: ON (B)(6) 2025, THIS PATIENT UNDERWENT AN ENDOVASCULAR TREATMENT FOR PARARENAL ABDOMINAL AORTIC ANEURYSM USING GORE® EXCLUDER® THORACOABDOMINAL BRANCH ENDOPROSTHESIS (TAMBE). THE USED DEVICES OTHER THAN TAMBE ARE LISTED BELOW: GORE® VIABAHN® VBX BALLOON EXPANDABLE ENDOPROSTHESIS: 6 COMPONENTS IN TOTAL, GORE® EXCLUDER® AAA ENDOPROSTHESIS: ONE CONTRALATERAL LEG, GORE® EXCLUDER® ILIAC BRANCH ENDOPROSTHESIS (IBE): ONE ILIAC BRANCH COMPONENT, GORE® DRYSEAL FLEX INTRODUCER SHEATH (DSF), GORE® TRI LUMEN CATHETER, - GORE® MOLDING & OCCLUSION BALLOON CATHETER. DURING THE PROCEDURE, INSERTION OF A 22FR DSF VIA THE LEFT FEMORAL ARTERY WAS ATTEMPTED BUT WAS DIFFICULT TO ADVANCE DUE TO CALCIFICATION. THE SHEATH WAS EXCHANGED FOR A 16FR DSF, BUT SIMILAR RESISTANCE WAS ENCOUNTERED. AFTER GUIDEWIRE EXCHANGE, BOTH 16FR AND 22FR DFSS WERE ADVANCED WITH RESISTANCE BUT SUCCESSFULLY INSERTED. WHILE POSITIONING THE AORTIC COMPONENT, WIRE WRAP OCCURRED AND WAS RESOLVED BY ROTATING THE GUIDEWIRE 360 DEGREES. THE AORTIC COMPONENT WAS DEPLOYED WITHOUT ISSUE. CANNULATION OF THE LEFT RENAL ARTERY WAS CHALLENGING, BUT AFTER GUIDEWIRE EXCHANGE, THE BRANCH COMPONEN

  Patient problems: Embolism/Embolus; Renal Impairment

  MAUDE report 23591329 ↗
• InjuryNov 11, 2025Patient Device Interaction Problem; Patient Device Interaction Problem

  IT WAS REPORTED TO GORE THAT ON (B)(6) 2025, THE PATIENT UNDERWENT ENDOVASCULAR TREATMENT FOR AN ABDOMINAL AORTIC ANEURYSM USING GORE EXCLUDER AAA ENDOPROSTHESES, AND GORE MOLDING & OCCLUSION BALLOON CATHETER AS AN ACCESSORY. AN ILIAC EXTENDER WAS DEPLOYED TOWARD THE RIGHT EXTERNAL ILIAC ARTERY, AND A MOB BALLOON WAS INFLATED TO ENSURE APPOSITION WITH THE VESSEL WALL. SUBSEQUENTLY, ANGIOGRAPHY REVEALED THE FORMATION OF A DISSECTION IN THE RIGHT EXTERNAL ILIAC ARTERY. A BARE STENT WAS ADDITIONALLY IMPLANTED AS TREATMENT. THE PATIENT TOLERATED THE PROCEDURE. THE PHYSICIAN¿S COMMENT: ¿ANGIOGRAPHY REVEALED A DISSECTION AFTER PLACEMENT OF THE ILIAC EXTENDER.¿

  Patient problems: Vascular Dissection

  MAUDE report 23520092 ↗
• InjuryAug 19, 2025Patient Device Interaction Problem; Patient Device Interaction Problem

  THE FOLLOWING INFORMATION WAS REPORTED TO GORE: ON (B)(6) 2025, THE PATIENT UNDERWENT ENDOVASCULAR TREATMENT FOR AN ABDOMINAL AORTIC ANEURYSM USING THE GORE® EXCLUDER® CONFORMABLE AAA ENDOPROSTHESIS, THE GORE® EXCLUDER® AAA ENDOPROSTHESIS, AND THE GORE® MOLDING & OCCLUSION BALLOON (MOB). AFTER DEPLOYMENT OF ALL STENT GRAFTS, THE PROXIMAL NECK OF THE AORTA WAS FURTHER COMPRESSED USING THE MOB TO REINFORCE FIXATION. DURING THIS PROCEDURE, AN AORTIC RUPTURE WAS CONFIRMED. TO REPAIR THE RUPTURE, AN AORTIC EXTENDER ENDOPROSTHESIS WAS DEPLOYED FROM BELOW THE LEFT RENAL ARTERY, BUT HEMOSTASIS COULD NOT BE ACHIEVED. ADDITIONAL STENT GRAFTS WERE PLACED USING THE CHIMNEY TECHNIQUE FROM BELOW THE RIGHT RENAL ARTERY AND INTO THE LEFT RENAL ARTERY, RESULTING IN SUCCESSFUL HEMOSTASIS. ATTENDING PHYSICIAN¿S COMMENT: THE RUPTURE WAS LIKELY CAUSED BY OVEREXPANSION DURING BALLOON COMPRESSION.

  Patient problems: Perforation of Vessels

  MAUDE report 22844270 ↗
• InjuryJul 31, 2025Patient Device Interaction Problem; Patient Device Interaction Problem

  ON (B)(6) 2025, THIS PATIENT UNDERWENT ENDOVASCULAR TREATMENT OF AN ABDOMINAL AORTIC ANEURYSM USING GORE® EXCLUDER® AAA ENDOPROSTHESIS AND GORE® MOLDING & OCCLUSION BALLOON CATHETER(MOB). AFTER ALL DEVICES WERE PLACED AS PLANNED, BALLOONING WAS PERFORMED USING MOB DEVICE. A DISSECTION NEAR THE ORIGIN OF THE LEFT RENAL ARTERY ON A CONFIRMATION ANGIOGRAPHY. THE PHYSICIAN ELECTED TO MONITOR IT, AND THE PROCEDURE WAS COMPLETED WITHOUT FURTHER TREATMENT. THE PATIENT TOLERATED THE PROCEDURE.

  Patient problems: Vascular Dissection

  MAUDE report 22683790 ↗
• InjuryJul 29, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE FOLLOWING INFORMATION WAS REPORTED TO GORE: ON (B)(6) 2025, THIS PATIENT UNDERWENT ENDOVASCULAR TREATMENT FOR AN ABDOMINAL AORTIC ANEURYSM USING GORE® EXCLUDER AAA ENDOPROSTHESES, AND GORE MOLDING & OCCLUSION BALLOON CATHETER AS AN ACCESSORY. A CONTRALATERAL LEG (PLC141200J) WAS DEPLOYED TOWARDS THE RIGHT COMMON ILIAC ARTERY, AND AN MOB BALLOON WAS INFLATED FOR APPOSITION. DUE TO A DROP IN BLOOD PRESSURE, ANGIOGRAPHY WAS PERFORMED FROM THE DISTAL SIDE, REVEALING A RUPTURE OF THE RIGHT COMMON ILIAC ARTERY. THE RIGHT INTERNAL ILIAC ARTERY WAS COIL EMBOLIZED, AND AN ADDITIONAL STENT GRAFT WAS IMPLANTED TOWARDS THE RIGHT EXTERNAL ILIAC ARTERY AS A TREATMENT. THE PATIENT TOLERATED THE PROCEDURE. THE PHYSICIAN¿S COMMENT: ¿THE PATIENT IS ELDERLY, AND THE VASCULAR WAS FAR MORE FRAGILE THAN EXPECTED.¿

  Patient problems: Perforation of Vessels

  MAUDE report 22641452 ↗
• InjuryJul 3, 2025Patient Device Interaction Problem; Patient Device Interaction Problem

  THE FOLLOWING INFORMATION WAS REPORTED TO GORE: ON (B)(6) 2025, THIS PATIENT UNDERWENT ENDOVASCULAR TREATMENT FOR AN ABDOMINAL AORTIC ANEURYSM USING GORE EXCLUDER CONFORMABLE AAA ENDOPROSTHESIS AND GORE EXCLUDER AAA ENDOPROSTHESES. GORE MOLDING & OCCLUSION BALLOON CATHETER WAS ALSO USED AS AN ACCESSORY. AFTER DEPLOYING ALL STENT GRAFTS AND INFLATING THE BALLOON INSIDE THEM, A PROXIMAL TYPE I ENDOLEAK WAS OBSERVED ON THE TRUNK IPSILATERAL LEG VIA CONTRAST IMAGING. AFTER ANOTHER BALLOON INFLATION, A DISSECTION OCCURRED JUST BELOW THE RIGHT RENAL ARTERY, AND THE TYPE I ENDOLEAK REMAINED. ALTHOUGH NO FURTHER TREATMENT WAS PERFORMED, AND THE PHYSICIAN DECIDED TO FOLLOW UP WITH THE PATIENT. THE PATIENT TOLERATED THE PROCEDURE. THE PHYSICIAN¿S COMMENT: ¿THE BALLOON MAY HAVE BEEN ADVANCED TOO FAR PROXIMALLY DURING THE INFLATION.¿

  Patient problems: Vascular Dissection

  MAUDE report 22392696 ↗
• InjuryJun 9, 2025Patient Device Interaction Problem; Patient Device Interaction Problem

  THE FOLLOWING INFORMATION WAS REPORTED TO GORE: ON (B)(6) 2025, THIS PATIENT UNDERWENT ENDOVASCULAR TREATMENT FOR AN ABDOMINAL AORTIC ANEURYSM USING GORE® EXCLUDER®AAA ENDOPROSTHESES AND GORE® MOLDING & OCCLUSION BALLOON CATHETER AS AN ACCESSORY. AFTER THE AORTIC EXTENDER WAS DEPLOYED, THE PHYSICIAN INFLATED THE MOB BALLOON INSIDE. SUBSEQUENTLY, AN ANGIOGRAPHY REVEALED RETROGRADE DISSECTION EXTENDING FROM THE PROXIMAL END OF THE AORTIC EXTENDER TO BELOW THE RIGHT RENAL ARTERY. AS THE DISSECTION WAS LOCALIZED, THE PROCEDURE WAS COMPLETED WITH BLOOD PRESSURE MANAGEMENT AND FOLLOW-UP OBSERVATION. THE PHYSICIAN¿S COMMENT: ¿THE CAUSE IS BELIEVED TO BE AN OVERLY FORCEFUL TOUCH-UP.¿

  Patient problems: Vascular Dissection

  MAUDE report 22173164 ↗
• InjuryMay 25, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2025, THIS PATIENT UNDERWENT ENDOVASCULAR TREATMENT OF AN ABDOMINAL AORTIC ANEURYSM USING GORE® EXCLUDER® CONFORMABLE AAA ENDOPROSTHESIS AND GORE® EXCLUDER® AAA ENDOPROSTHESIS. AFTER ALL STENT GRAFTS WERE PLACED, BALLOONING WAS PERFORMED USING GORE® MOLDING & OCCLUSION BALLOON CATHETER(MOB). IT WAS CONFIRMED THAT THE LEFT INTERNAL ILIAC ARTERY WAS EMBOLIZED ON THE CONFIRMATION ANGIOGRAPHY. IT WAS ASSUMED THAT A THROMBUS IN THE LEFT COMMON ILIAC ARTERY MIGHT HAVE DISPERSED DURING BALLOONING AND CAUSED AN EMBOLIZATION OF THE INTERNAL ILIAC ARTERY, BUT NO FURTHER TREATMENT WAS PERFORMED. THE PATIENT TOLERATED THE PROCEDURE.

  Patient problems: Embolism/Embolus

  MAUDE report 22082842 ↗
• InjuryMay 21, 2025Patient Device Interaction Problem; Patient Device Interaction Problem

  THE FOLLOWING INFORMATION WAS REPORTED TO GORE: ON (B)(6) 2025, THIS PATIENT UNDERWENT ENDOVASCULAR TREATMENT FOR AN ABDOMINAL AORTIC ANEURYSM USING GORE® EXCLUDER® AAA ENDOPROSTHESES AND GORE® MOLDING & OCCLUSION BALLOON CATHETER AS AN ACCESSORY. IN THE FINAL ANGIOGRAPHY, A TYPE I ENDOLEAK WAS OBSERVED ON THE DISTAL SIDE OF THE RIGHT CONTRALATERAL LIMB. AFTER PERFORMING A TOUCH-UP WITH A MOB BALLOON, CONTRAST LEAKAGE WAS OBSERVED NEAR THE DISTAL END OF THE CONTRALATERAL LEG, INDICATING VASCULAR INJURY. AS A TREATMENT, AN ADDITIONAL STENT GRAFT WAS INTENTIONALLY IMPLANTED TO EXTEND THE CONTRALATERAL LEG TO THE RIGHT EXTERNAL ILIAC ARTERY. THE PATIENT TOLERATED THE PROCEDURE. PHYSICIAN'S COMMENT: ¿THE CAUSE IS BELIEVED TO BE THE STRONG TOUCH-UP PERFORMED FOR THE ENDOLEAK.¿

  Patient problems: Perforation of Vessels

  MAUDE report 22058822 ↗
• InjuryMay 8, 2025Patient Device Interaction Problem; Patient Device Interaction Problem

  THE FOLLOWING INFORMATION WAS REPORTED TO GORE: ON (B)(6) 2025, THIS PATIENT UNDERWENT AN ENDOVASCULAR TREATMENT FOR ABDOMINAL AORTIC ANEURYSM USING GORE® EXCLUDER® CONFORMABLE AAA ENDOPROSTHESIS AND GORE® EXCLUDER® AAA ENDOPROSTHESIS. WHEN DEPLOYING A CONTRALATERAL LEG COMPONENT ON THE LEFT SIDE, THE INTERNAL ILIAC ARTERY WAS UNINTENTIONALLY COVERED. THE PHYSICIAN ATTEMPTED TO PUSH THE CONTRALATERAL LEG UP BY A GORE® MOLDING & OCCLUSION BALLOON CATHETER. AFTER THIS ATTEMPT, RUPTURE OF THE LEFT COMMON ILIAC ARTERY WAS CONFIRMED. AN ILIAC EXTENDER WAS PLACED TO COVER THE RUPTURED SITE. THE PROCEDURE WAS CONCLUDED WITH UNINTENTIONAL COVERAGE OF THE LEFT INTERNAL ILIAC ARTERY. THE REPORTING PHYSICIAN COMMENTED AS FOLLOWS: DURING ANGIOGRAPHY, THE LEFT ILIAC BIFURCATION WAS MISREAD.

  Patient problems: Perforation of Vessels

  MAUDE report 21983008 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K172567. One submission often covers many models, so check the product and lot details in each record.

• Z-2340-2021 · Jul 12, 2021 · Open, Classified
  Gore Molding & Occlusion Balloon Catheter, REF Catalogue Number MOB37, SN XXXXXXXX, 10 mm - 37 m 10 Fr, Guidewire Compatibility 0.035", STERILE EO, CE2797, UDI: (00)733132639489